Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Paclitaxel in Triple Negative Breast Cancer (TNBC)

Conditions

Breast Cancer

Keywords

triple negative breast cancer, fine line chemotherapy

Brief summary

This is a prospective, multi-center, open-labeled, randomized phase III clinical trial comparing overall response rate (ORR), progression free survival (PFS), overall survival (OS) and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine paclitaxel combination (GT).

Detailed description

The previous phase II study showed that gemcitabine and cisplatin combination (GP) is an effective regimen in triple negative breast cancer (TNBC). The potential therapeutic effects of GP in advanced TNBC deserve further evaluation yet. Eligible patients are randomly assigned to receive either GP or GT regimen to verify the hypothesis.

Xichun Hu, Jun Cao, Biyun Wang, Jian Zhang, Leiping Wang et al. (7 authors)

Cancer Research2021-02-151 citations

10.1158/1538-7445.sabcs20-ps12-11

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Yizhao Xie, Bingxin Gu, Xichun Hu, Yingjian Zhang, Jian Zhang et al. (11 authors)

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10.2147/cmar.s204364

Pretreatment 18F-FDG Uptake Heterogeneity Predicts Treatment Outcome of First-Line Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer

Chengcheng Gong, Guang Ma, Xichun Hu, Yingjian Zhang, Zhonghua Wang et al. (11 authors)

The Oncologist2018-08-0627 citations

10.1634/theoncologist.2018-0001

Biomarker assessment of the CBCSG006 trial: a randomized phase III trial of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer.

Zhang J, Lin Y, Sun XJ, Wang BY, Wang ZH, Luo JF, Wang LP, Zhang S, Cao J, Tao ZH, Wu J, Shao ZM, Yang WT, Hu XC.

2018-08-0155 citations

10.1093/annonc/mdy209

Updated survival data and biomarker assessment of the CBCSG006 trial: A randomized phase III trial of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer.

Jian Zhang, Ying Lin, Xichun Hu, Wentao Yang, Xiangjie Sun et al. (14 authors)

Journal of Clinical Oncology2018-05-20

10.1200/jco.2018.36.15_suppl.1093

Abstract P3-10-02: Gemcitabine with cisplatin or paclitaxel in metastatic triple-negative breast cancer

Xichun Hu, Binghe Xu, Li Cai, Zhonghua Wang, Biyun Wang et al. (20 authors)

Cancer Research2015-05-01

10.1158/1538-7445.sabcs14-p3-10-02

Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial.

Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, Yin YM, Wu CP, Jiang ZF, Wang XJ, Lou GY, Liu DG, Feng JF, Luo JF, Sun K, Gu YJ, Wu J, Shao ZM.

2015-03-18206 citations

10.1016/s1470-2045(15)70064-1

Interventions

DRUGGemcitabine,cisplatin

Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1

DRUGGemcitabine, Paclitaxel

Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Paclitaxel 175 mg/m2, IV, 3h,D1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

1. Females with age between 18 and 70 years old 2. Histological proven unresectable recurrent or advanced breast cancer 3. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (IHC) test. For patients with ER negative, PR negative, Her2 two plus, a negative Her2 gene amplification should be verified with FISH test. Her2 one plus may consider FISH verification. 4. No prior chemotherapy for metastatic breast cancer. Prior use of taxanes in the adjuvant/neoadjuvant setting is acceptable if completed 6 months prior to enrollment 5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST) 6. Performance status not more than 1 7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function 8. Life expectancy greater than 12 weeks 9. No serious medical history of heart, lung, liver and kidney 10. Provision of written informed consent prior to any study specific procedures 11. Patients with good compliance

Exclusion criteria

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound) 2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study 3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previously administered radiotherapy 4. Treatment with an investigational product within 4 weeks before the first treatment 5. Symptomatic central nervous system metastases, except for patients with stable and asymptomatic brain metastases who have completed a course of cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration 6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 7. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 8. Uncontrolled serious infection

Design outcomes

Primary

Measure	Time frame
PFS (Progression Free Survival)	6 weeks

Secondary

Measure	Time frame
Objective Response Rate (ORR)	6 weeks

Countries

China

Outcome results

None listed